Sensors for drug delivery devices

Abstract

The present invention relates to a sensor for a drug delivery device. In particular, it relates to a sensor for measuring at least one physical or chemical parameter of a cartridge filled with a liquid substance. The present invention also relates to a drug delivery device equipped with such a sensor, wherein the sensor comprises: a planar flexible foil having a first portion and having a second portion separated from the first portion; at least one measuring electrode, which is located on the flexible foil, wherein the flexible foil can be wound into a wound configuration, in which the foil forms at least a first winding, the inner diameter of the first winding being equal to or greater than the outer diameter of the cartridge, wherein in the wound configuration the first portion and the second portion at least partially overlap; at least one fastener, which is located in one of the first and second portions and is configured to be connected to the other of the first and second portions for holding the flexible foil in a wound configuration.

Description

[0001] This invention application is a divisional application based on an invention patent application with an application date of July 26, 2016, application number 201680044445.7 (international application number PCT / EP2016 / 067811) and name “Sensor for drug delivery device”. Technical Field

[0002] The present invention relates to the field of measuring at least one physical or chemical parameter of a cartridge filled with a liquid substance, typically a medicament. In another aspect, the present invention relates to a drug delivery device, in particular an injection device for setting and dispensing a dose of a liquid medicament. Background Art

[0003] Drug delivery devices for setting and dispensing one or more doses of liquid medicament are well known in the art. Typically, such devices have a substantially similar effect to that of ordinary syringes.

[0004] Drug delivery devices like pen injectors must meet some user-specific needs. For example, the patient suffers from a chronic disease such as diabetes, the patient may be physically weak, or may have impaired vision. Therefore, a suitable drug delivery device, particularly intended for home medication, needs to be structurally robust and should be easy to use. Furthermore, the operation and general handling of the device and its components should be understandable and easy to understand. Such an injection device should provide for setting a dose of a variable size of a medicament and subsequently dispensing it. Furthermore, the dose setting and dose dispensing procedures must be easy to operate and must be clear.

[0005] Typically, such devices comprise a housing or a specific cartridge holder adapted to accommodate a cartridge at least partially filled with a medicament to be dispensed. Such devices further comprise a drive mechanism, typically having a movable piston rod adapted to operatively engage with a piston of the cartridge. By means of the drive mechanism and its piston rod, the piston of the cartridge can be moved in a distal or dispensing direction and thus a predetermined amount of medicament can be expelled via a piercing member releasably connected to a distal portion of the housing of the drug delivery device.

[0006] The drug delivery device is provided with a medicament to be dispensed and is contained in a multi-dose cartridge. Such a cartridge generally comprises a glass barrel sealed in the distal direction by means of a pierceable seal and further sealed in the proximal direction by a piston. In the case of a reusable drug delivery device, an empty cartridge can be replaced with a new one of said cartridges. In contrast, a disposable drug delivery device is completely discarded when the medicament in the cartridge is dispensed or used up.

[0007] It is generally desirable to determine the amount of medicament remaining in the cartridge while the cartridge is arranged inside the drug delivery device. It is generally known in the prior art to implement capacitance measurement or capacitance determination of the cartridge of the fill level. At least two electrodes are provided on the cartridge itself or inside the cartridge holder part of the drug delivery device. Since the dielectric properties of the liquid material inside the cartridge are significantly different from the dielectric properties of other surrounding materials, such as glassy materials, the cartridge is made of a rubber-based material to form the proximal piston of the cartridge, and the capacitance between the electrodes located on the radially opposite side wall parts of the cartridge is measured in relation to the fill level of the cartridge and / or the axial position of the piston inside the cartridge.

[0008] For example, document WO 2014 / 052997 A1 discloses a corresponding dispensing device having at least one pair of capacitance measuring electrodes arranged in the outer region of a medicament container for determining the dielectric constant of a corresponding medium in the intermediate region between the measuring electrodes. In addition, a sheath is described which is arranged around the container and surrounds the measured material in a sheath-like manner.

[0009] In order to accurately measure the physical or chemical parameters of the cartridge, in particular to measure the filling level of the liquid substance contained therein, it is necessary to arrange at least one or more measuring electrodes on the periphery of the barrel of the cartridge. The correct position of the electrode relative to the cartridge may be particularly relevant to obtaining accurate and reliable measurement results. It is generally conceivable to fix the electrodes and the electronic components of the sensor to the periphery of the cartridge, but this will significantly increase the overall cost of manufacturing the cartridge. Document WO2014 / 052997 further suggests the use of a specific carrier to carry the measuring electrodes. Here, the carrier may be part of a drug delivery device. Providing such an additional carrier requires significant design of the existing drug delivery device, which is to be avoided.

[0010] Purpose of the Invention

[0011] Therefore, one object of the present invention is to provide a sensor for measuring at least one physical or chemical parameter of a cartridge filled with a liquid substance. The sensor should provide a reliable and accurate measurement of the required parameter, in particular a reliable and accurate measurement of the filling level of the cartridge. In addition, the sensor should be suitable for implementation into existing drug delivery devices or existing concepts of drug delivery devices, so that use within or with a drug delivery device requires only minimal modifications to the drug delivery device. In addition, the sensor should be operable with standard and commercially distributed cartridges, as cartridges are well known in the art. Therefore, the operation of the sensor for measuring at least one physical or chemical parameter should avoid and circumvent the necessity for any modification of the cartridge. Summary of the invention

[0012] The present invention specifically relates to the following:

[0013] 1. A sensor for measuring at least one physical or chemical parameter of a cartridge (50) filled with a liquid substance, the sensor comprising:

[0014] a planar flexible foil (11) having a first portion (13, 23) and having a second portion (15, 25) separate from the first portion (13, 23),

[0015] - at least one measuring electrode (32, 34), said at least one measuring electrode (32, 34) being located on said flexible foil (11),

[0016] - wherein the flexible foil (11) is capable of being wound into a wound configuration (W), in which the foil (11) forms at least a first winding (22, 24, 26), the inner diameter (D) of the first winding (22, 24, 26) being equal to or greater than the outer diameter of the cartridge (50), wherein in the wound configuration (W) the first portion (13, 23) and the second portion (15; 25) at least partially overlap,

[0017] - at least one fastener (33, 36) located in the first portion (13, 23) and configured to be connected to the second portion (15, 25) for holding the flexible foil (11) in the wound configuration (W).

[0018] 2. Sensor according to item 1, wherein the at least one fastener (33, 36) is configured to keep the flexible foil (11) in a wound configuration (W) forming a self-supporting tubular sheath.

[0019] 3. A sensor according to item 2, wherein the cartridge is insertable into the first winding (22, 24, 26) along a longitudinal direction, wherein the longitudinal direction coincides with the axial direction or longitudinal axis of the tubular first winding. 4. A sensor according to any of the preceding items, wherein the fastener (36) is located at a lateral side edge (18, 20) of the flexible foil (11).

[0020] 5. A sensor according to any of the preceding clauses, wherein the fastener (36) in the first portion (23) comprises an adhesive and wherein the first portion (23) is bonded to a second portion (25) of the flexible foil (11) when the flexible foil (11) is in a wound configuration (W).

[0021] 6. Sensor according to item 5, wherein the fastener (23) extends in a longitudinal or axial direction along a lateral side edge (18) of the planar flexible foil (11).

[0022] 7. A sensor according to any of the preceding items, wherein the fastener (36) located in the first part (23) comprises a bondable or weldable structure, and the bondable or weldable structure is used to be bonded to the second part (25) of the flexible foil (11) when the flexible foil (11) is in a wrapped structure (W).

[0023] 8. The sensor according to any of the preceding clauses, wherein the fastener (36) and the second portion (25) are located on opposite sides (3, 4) of the flexible foil (11).

[0024] 9. A sensor according to claim 1, wherein a fastener (33) located in the first part (13) protrudes from the plane of the flexible foil (11), and wherein the second part (15) includes a recess (35) which accommodates the fastener (33) when the flexible foil (11) is in a wrapped configuration (W).

[0025] 10. The sensor according to any of the preceding clauses, further comprising a processor (40) electrically connected to at least one measuring electrode (32, 34) located in the sensing area (12) of the flexible foil (11).

[0026] 11. A sensor according to items 9 and 10, wherein a processor (40) protruding from the plane of the flexible foil (11) forms a fastener (33) sized to match the recess (35) of the second portion (15).

[0027] 12. The sensor according to item 10 or 11, further comprising an antenna (44) located in the communication area (14) of the flexible foil (11) and electrically connected to the processor (40).

[0028] 13. A sensor according to claim 12, wherein the flexible foil (11) is electrically insulating, and wherein the at least one measuring electrode (32, 34) is permanently and fixedly connected to the flexible foil (11) in the region of a sensing zone (12), and wherein the antenna (44) is permanently and fixedly connected to the flexible foil (11) in the region of a communication zone (14) separate from the sensing zone (12).

[0029] 14. The sensor according to any one of items 10 to 13, further comprising an electrical shield (48) located on the flexible foil (11) and electrically connected to the processor (40).

[0030] 15. A sensor according to items 13 and 14, wherein the electrical shielding (48) is located in the communication area (14) of the flexible foil (11) but on the side (3) of the flexible foil (11) opposite to the side (4) of the flexible foil (11) on which the antenna (44) is located.

[0031] 16. A sensor according to any one of items 12 to 15 above, wherein the sensing area (12) and the communication area (14) of the flexible foil (11) are arranged adjacent to each other along the transverse direction (u), so that when the flexible foil (11) is in a winding structure (W), the sensing area forms a first winding (22) and the communication area (14) forms a second winding (24) surrounding the first winding (22).

[0032] 17. Sensor according to item 16, wherein the at least one measuring electrode (32, 34) and the electrical shielding (48) are located on the same side of the flexible foil (11).

[0033] 18. A sensor according to claim 16, wherein the flexible foil (11) further comprises a protection zone (16), the protection zone (16) being located adjacent to the communication zone (14) and being configured to form a third winding (26) surrounding the second winding (22) when the flexible foil (11) is in a winding configuration (W).

[0034] 19. A drug delivery device for setting and dispensing a certain dose of a liquid medicament, comprising a housing (80), the housing (80) having a tubular container (90) and having a sensor (10) according to any of the preceding items, the tubular container (90) accommodating a cartridge (50) filled with the medicament, the sensor being arranged and fixed inside the container (90) of a winding structure (W) to receive the cartridge (50) inside the first winding (22).

[0035] 20. A drug delivery device according to claim 19, wherein the container (90) is located inside a cartridge holder (84) of the housing (80), wherein a proximal portion of the cartridge holder (84) housing the cartridge (50) is detachably connected to a distal portion of a body (82) of the housing (80), and wherein the body (82) houses a drive mechanism (60) configured to apply a distally directed pressure to a piston (52) of the cartridge (50).

[0036] In one aspect, the present invention relates to a sensor for measuring at least one physical or chemical parameter of a cartridge, wherein the cartridge is filled with a liquid substance. Typically, the cartridge is filled with a liquid medicament. The cartridge may comprise a tubular barrel, for example made of glass or some other material that is substantially inert to the liquid substance contained therein.

[0037] The sensor comprises a planar flexible foil having a first portion and having a second portion separated from the first portion. In other words, the first and second portions of the planar flexible foil are non-overlapping. The first and second portions of the planar flexible foil are completely separated from each other. In addition, the first and second portions of the planar flexible foil are arranged at a predetermined distance relative to each other. The sensor further comprises at least one measuring electrode located on the flexible foil. The flexible foil may further be wound or coiled into a winding or coiled configuration, wherein the foil forms at least a first winding, the inner diameter of the at least first winding being equal to or greater than the outer diameter of the cartridge.

[0038] Typically, the flexible foil may be wound into a tubular structure or tubular sheath to receive a tubular cartridge therein. At least a first winding is typically folded or wound such that a cartridge may be inserted into the first winding along a longitudinal direction, wherein the longitudinal direction coincides with an axial direction or longitudinal axis of the tubular first winding.

[0039] The sensor further comprises at least one fastener, the at least one fastener being located in the first portion of the flexible foil. The fastener is configured to be connected to the second portion of the foil for holding the flexible foil in a wound configuration. By means of the fastener being connected to the second portion, the first and second portions of the flexible foil are held together, thereby preventing automatic unfolding or unwinding of the flexible foil. By means of the fastener, a stable and self-supporting tubular sheath can be formed simply by winding the planar flexible foil and by connecting at least one fastener to its second portion.

[0040] By means of at least one fastener, the initially planar flexible foil and the initially planar sensor can be wound to form a tubular sheath. Once such a sheath is formed, the wound sensor or the wound planar flexible foil on which the at least one measuring electrode is located can be easily assembled and positioned inside the housing of the drug delivery device. It is quite straightforward to insert the wound flexible foil into a correspondingly shaped tubular container of the housing of the drug delivery device. To this end, the drug delivery device, in particular its housing, only needs to provide a container of corresponding shape, in which the wound flexible foil (i.e., the wound sensor) can be positioned and fixed.

[0041] Thus, at least one fastener facilitates the assembly process and helps to keep the sensor in a predetermined geometry even before assembly inside the drug delivery device. The predefined geometry is limited only by the position of the fastener and the first or second portion of the corresponding configuration of the foil. If, for example, the container of the drug delivery device receiving the wound or coiled flexible foil is subject to unavoidable manufacturing tolerances, the diameter of the wound foil will probably be at least slightly modified because the flexible foil tends to unfold once it is located inside the container. Only a slight but uncontrolled unfolding or opening of the initially folded or wound flexible sensor may have an adverse effect on the accuracy and repeatability of the signal measured by the sensor. By means of the fastener, a series of identically wound sensors can be provided with a high degree of repeatability and accuracy. This allows to improve the accuracy and reproducibility of the data or signals measured with the individual sensors.

[0042] In addition, at least one fastener is used to hold the flexible foil in a wound configuration. In a wound or coiled configuration, the planar flexible foil inherently exhibits increased mechanical stability, making it unnecessary to provide a separate carrier in the drug delivery device to act as a mechanical support structure for the sensor. In this way, modifications to the drug delivery device for receiving and accommodating the wound flexible foil can be kept to a minimum.

[0043] When the flexible foil is wound or rolled into a winding configuration, its first and second parts at least partially overlap. Therefore, the first and second parts of the planar flexible foil are selected and defined so that the first and second parts of the planar flexible foil overlap in the radial direction. Here, the radial direction refers to the geometry of the tubular cartridge or the tubular winding flexible foil. The radial direction extends substantially perpendicular to the plane of the initial planar foil. Therefore, the first and second parts are located at a clear part of the planar flexible foil, and when the planar flexible foil is converted into its winding configuration, these parts directly overlap and contact. The planar flexible foil is generally a rectangular structure with four sides.

[0044] The planar flexible foil is windable or spoolable relative to a virtual winding axis or winding axis extending parallel to the lateral sides of the foil. The initial planar flexible foil extends in a longitudinal direction and a transverse direction. In final assembly, for example in a drug delivery device that also accommodates a cartridge, the longitudinal direction of the wound flexible foil is substantially parallel to or co-aligned with the longitudinal or axial direction of the tubular cartridge. The transverse direction of the planar flexible foil extends along the periphery of the tubular side wall of the cartridge. In other words, when wound in a wound configuration, the transverse direction of the flexible foil extends in a tangential direction around the tubular side wall of the barrel of the cartridge.

[0045] According to one embodiment, the fasteners are positioned at the lateral side edges of the flexible foil. In this way, a lateral end of the flexible foil, and thus one end of the winding or wound configuration, can be connected to the winding located below. Providing the fasteners at the lateral side edges can provide a rather closed and compact structure of the wound sensor. Using the fasteners at the lateral side edges of the flexible foil, the side edge being the last edge of the flexible foil is bent or wound onto the winding or winding located below the wound configuration of the flexible foil, so that the wound configuration of the sensor is slightly tubular without any significant radial protrusions at its outwardly facing side walls or inwardly facing side walls.

[0046] Until the initial planar flexible foil is fully coiled, the thickness of the flexible foil is relatively small and the number of coils or wraps to be formed is relatively small, the resulting wound configuration, e.g. a tubular coil form of the planar flexible foil, may comprise relatively thin side walls which enable smooth and easy integration and assembly of the sensor inside the drug delivery device.

[0047] According to another embodiment, the fastener located in the first part contains an adhesive so that the adhesive can be bonded to the second part of the flexible foil when the flexible foil is in a wound configuration. In particular when the fastener is located at the lateral side edge of the last coil of the flexible foil, it is particularly beneficial when the fastener extends all along said lateral side edge in the longitudinal extension or axial direction when the flexible foil is converted into its wound configuration and the fastener is completely provided with adhesive. In this way, the entire lateral side edge of the flexible foil can be connected to the second part and thus to the coil, winding or winding of the foil located radially below. In this way, a wound sensor with a relatively smooth outer surface can be provided, which is particularly beneficial for smoothly assembling and inserting the wound sensor in the longitudinal direction into a corresponding container or chamber of the housing of the drug delivery device.

[0048] According to another embodiment, the fastener located in the first part comprises a bondable or weldable structure for bonding or welding to the second part of the flexible foil when the flexible foil is in a wound configuration. Here, the fastener may comprise a specific chemical or heat-sensitive material or a corresponding material strip, which may extend all along the side edges of the flexible foil. Once the flexible foil is in its wound configuration, bonding or welding may be induced by chemical agents and / or by applying thermal energy. It is generally conceivable that any portion of the planar flexible foil is bonded or welded to an overlapping and adjacently positioned portion of the flexible foil when the wound configuration is formed.

[0049] In this way and according to this particular embodiment, the at least one fastener can be located anywhere on the planar flexible foil. It is generally conceivable that the at least one fastener consists of a predetermined portion, typically the second portion, as described above. When the second portion substantially overlaps the fastener of the wound or coiled configuration, the fastener and the second portion, optionally also located radially below, may be subjected to a welding procedure, thereby forming a permanent and non-detachable wound or coiled configuration of the sensor and its flexible foil.

[0050] According to a further embodiment, fastener and second portion are positioned on the opposite side of flexible foil.In the initial planar configuration of flexible foil, fastener can be arranged on the upper side of foil, and second portion attached or connected with fastener is positioned on the opposite side of flexible foil, therefore on its lower side.When being wound configuration, fastener can be arranged on the inner side facing of wound foil, and second portion can be arranged on the outer side facing of wound foil.In this way and when being formed as tubular winding, the fastener positioned in first portion directly contacts with second portion.In other configurations or embodiments, it is also conceivable that fastener and second portion are positioned in flexible foil or extend through flexible foil.Utilize this embodiment, fastener and second portion are configured to form forced interlock (positive interlock), to stop the automatic unfolding or unwinding of the flexible foil of winding or winding.

[0051] According to a further embodiment, the fastener is located in the first part and protrudes from the plane of the flexible foil. Accordingly, the second part includes a recess to receive the fastener when the flexible foil is in a winding configuration. In this way, a forced interlocking of the protruding fastener and the recessed portion of the flexible foil can be obtained. Typically, the recess and the fastener are spaced a distance apart in a transverse direction corresponding to the circumference of at least the first winding. In addition, the fastener and the recess are substantially overlapped in the longitudinal or axial direction. Therefore, when winding around the imaginary tubular barrel of the cartridge, when forming at least the first winding, the protruding fastener fits into the recess. Due to this type of forced interlocking, the winding or coiled flexible foil is prevented from automatically unfolding or unwinding. By means of at least one fastener engaged with the recess, a winding sensor of a fairly stable and self-supporting configuration is obtained, which is particularly suitable for being inserted into a correspondingly shaped container of the housing of a drug delivery device in the longitudinal direction.

[0052] Regardless of the specific connection of the fastener and the second part of the flexible foil, the mutual fastening prevents a mutual longitudinal or axial displacement of, for example, the first winding and a further winding, such as the second or third winding, when the wound sensor is inserted, for example, in the longitudinal direction into a container of a drug delivery device. Thus, the interlock obtainable by the fastener connected to the second part acts not only in the transverse direction but also in the longitudinal direction.

[0053] In another embodiment, the sensor further comprises a processor, the processor being electrically connected to at least one measuring electrode, wherein at least one measuring electrode is located in the sensing zone of the flexible foil. Typically, the sensor comprises at least two measuring electrodes, both of which are electrically connected to the processor. The processor, which is typically implemented as a microcontroller or similar data processing device, is connected to the flexible foil. It is typically arranged in or below the sensing zone, typically in the lateral border regions of the sensing zone of the flexible foil.

[0054] In addition and according to a further embodiment, the sensor also comprises an antenna in the communication zone of the flexible foil. The antenna is electrically connected to the processor. The antenna can provide dual functions. The antenna can provide wireless communication between the sensor and, for example, a reader or another data processing device (such as a smart phone, a tablet computer, a personal computer, etc.). In addition, the antenna can be implemented as a radio frequency identification (RFID) device. It can be implemented as a near field communication (NFC) device so that the antenna provides wireless coupling with an energy source to provide electrical energy to the processor and / or the electrode. By implementing the antenna as an RFID or NFC component, the sensor can function as a passive RFID or NFC device, without the need for a separate energy source. In this way, the sensor can have no energy source of its own. This enables such a sensor to be implemented at low cost and in a space-saving manner. In addition, due to the lack of its own energy source, the overall service life of the sensor can be extended, and no longer depends on the service life of the energy source.

[0055] The first and second electrodes are not only located in the sensing area, but are also permanently fixedly connected to the flexible foil in the area of ​​the sensing area. In the same way, the antenna is also fixedly connected to the foil in the communication area separated from the sensing area. By connecting both the electrodes and the antenna to the same flexible foil, the flexible foil is used as a common support or substrate for the sensor. Typically, at least the first and second electrodes and the antenna are printed or coated on the surface of the flexible foil, which is usually electrically insulating. Therefore, the foil actually acts as a flexible planar substrate or mechanical support for the first and second electrodes and the antenna. Implementing the electrodes and the antenna on the same flexible foil is beneficial to the assembly process of the sensor and the cartridge.

[0056] When the sensing area of ​​the planar flexible foil is arranged or connected to the cartridge, the antenna is automatically correctly positioned relative to the cartridge. Then, a separate step of antenna assembly, in particular establishing mutual electrical interconnection of the first and / or second electrodes with the processor and / or the antenna, may become superfluous. Furthermore, with the first and second electrodes printed or connected to the planar flexible foil, at least the two electrodes are inherently correctly positioned relative to each other. During assembly of the flexible foil and the cartridge, the relative position and / or orientation of the first and second electrodes remains and may only be changed due to geometric deformations of the flexible foil.

[0057] According to another embodiment, the sensor further comprises an electric shield also located on the flexible foil and electrically connected to the processor. Typically, the electric shield extends over the entire communication zone. The electric shield substantially overlaps or completely covers and surrounds the antenna. Typically and in the final assembled configuration, the electric shield is wrapped around the sensing zone, thereby acting as a cladding for the sensing zone.

[0058] In this way, the sensing area, and therefore its rather sensitive electrodes, can be effectively protected and shielded from any potential changes in the electromagnetic field in the vicinity of the sensor. In addition, the electrical shield can be used as a proximity sensor or touch sensor, by which an object such as a finger in the vicinity of the sensor can be detected. In this way, the electrical shield not only serves to protect the first and second electrodes from radiated EMI, but also provides an effective means to compensate or counteract any adverse effects of the first and second electrode arrangements in response to the proximity of an object, which may change the dielectric properties in the vicinity of the sensor.

[0059] According to another embodiment, the electric shield is also at least partially located in the communication zone or overlaps with the communication zone. However, the electric shield is electrically isolated from the antenna. The electric shield and the antenna are further located on opposite sides of the flexible foil. Since the flexible foil is electrically insulating, the simple arrangement of the antenna and the electric shield on opposite sides of the flexible foil, such as the upper side and the lower side, inherently provides sufficient electrical insulation therebetween. In addition, in the final assembly configuration in which the communication zone is wound around and receives the periphery of the tubular cartridge, the antenna, which is usually located on the outward-facing portion of the foil, is radially separated from the electric shield, which is usually located on the inward-facing portion of the wound or coiled flexible foil. In the final assembly configuration in which the flexible foil is wound around the tubular barrel of the cartridge, the electric shield is usually radially sandwiched between the communication zone and the induction zone.

[0060] According to another embodiment, the foil is substantially transparent. The foil typically comprises or is made of a transparent polymer. The foil may comprise at least one of the materials polycarbonate, polyimide or polyvinyl chloride (PVC) or a combination thereof. In addition, the foil may be printed or coated with a conductive structure, such as at least a first and a second electrode, an antenna or an electrical shield. In addition, the first and second electrodes, the processor, the antenna and the electrical shield may be electrically connected by means of a plurality of conductive paths that may be printed or coated on the foil simultaneously. The conductive path may be the same material as the antenna, the shield and / or the electrode. Typically, at least one of the antenna, the shield, the first or second electrode and the conductive path comprises a metal and a conductive material, or even consists of such a conductive material.

[0061] The conductive structures on the flexible foil may also be applied by any suitable thin film deposition technique such as sputtering, spraying or coating by means of various chemical vapor deposition techniques.

[0062] By arranging all the electrical components of the sensor on the same planar flexible foil, mechanical interfaces between the electrical components of the sensor, such as plugs or other connectors, become superfluous. Due to the transparent foil and / or transparent electrodes, conductive paths, shielding or antennas, for example, a glass cartridge can still be visually inspected. The electronic components of the sensor, i.e. the first and second electrodes, the antenna or the shielding, may comprise or may consist of conductive and substantially transparent indium tin oxide (ITO). Alternatively, the electronic components may comprise or consist of comparable conductive and transparent materials.

[0063] The contents of the transparent and glass cartridges remain visually inspectable due to the transparent foil and / or transparent electronic structure attached thereto or embedded therein. Visual inspectability of the cartridge interior is particularly important for intuitively controlling whether the contents of the cartridge, particularly liquid medicaments, may be subject to coagulation or flocculation or some other detrimental effect or phenomenon.

[0064] In a further embodiment, the sensing area and the communication area of ​​the flexible foil are arranged adjacent in the transverse direction, such that when the flexible foil is in a wound or coiled configuration, the sensing area forms a first winding and the communication area forms a second winding surrounding the first winding. When at least one measuring electrode and the electric shield are located on the same side of the flexible foil, and when the antenna is located in a configuration overlapping the electric shield but on the opposite side of the foil, then when the sensor is in a wound configuration with the measuring electrode facing radially inwards and being located in the region of the first or inner winding or coil, the electric shield is radially sandwiched between the antenna and the measuring electrode.

[0065] In another embodiment, the flexible foil further comprises a protection zone arranged adjacent to the communication zone, the protection zone being configured to form a third winding surrounding the second winding when the flexible foil is in a winding configuration. In this way, the planar flexible foil comprises at least three zones arranged adjacent to each other in a transverse direction. Typically, each of the at least three zones extends over the longitudinal extension of the entire flexible foil, thus extending from the distal edge towards the proximal edge. Starting from the side edge, the sensing zone is first placed together with at least one measuring electrode. Contrary to this transverse side edge, the communication zone is arranged near or adjacent to the sensing zone and further follows the protection zone in a transverse direction. In this way, the communication zone is laterally sandwiched between the sensing zone and the protection zone.

[0066] When in a coiled or wound configuration, the protection zone provides mechanical protection only for the first and second windings located below. Since the antenna is typically located on the outwardly facing side of the second winding, the protection zone is configured to provide mechanical protection for the antenna. Since the wound sensor is configured and is intended to be positioned and inserted into a container of a drug delivery device in a longitudinal or axial direction, the protection zone protects the antenna from mechanical influences, such as scratches.

[0067] When the fastener is configured as an adhesive strip or a bondable or weldable structure, it is usually located at the free side edge of the protected area, forming the lateral free end of the wound flexible foil. In this case, the second portion can substantially overlap the transition area between the second and third windings, while being located on the opposite side of the flexible foil compared to the side on which the at least one bondable or weldable fastener is located.

[0068] It is generally conceivable that the sensing area forming the first winding, the communication area forming the second winding and the protection area forming the third winding are all of substantially the same lateral dimensions. However, depending on the specific requirements of the drug delivery device and / or the cartridge, it is also conceivable that the lateral and / or longitudinal extensions of the sensing area, the communication area and the protection area vary to a lesser or greater extent.

[0069] According to another aspect, the present invention also relates to a drug delivery device for setting and dispensing a dose of a liquid medicament, which is usually contained in a cartridge. The drug delivery device comprises a housing having a tubular container to receive and hold the cartridge filled with the medicament. The drug delivery device further comprises a sensor as described above, which is arranged and fixed inside the specific container when the sensor is in a wound configuration. In this way, the wound sensor is configured to receive the cartridge inside the first winding. When arranged inside the container of the drug delivery device, the wound or wrapped sensor forms a kind of envelope of the inner side wall of the tubular container. In the final assembly configuration in which the cartridge is located inside the container, the wound sensor is radially sandwiched between the cartridge and the side wall of the container.

[0070] The coiled or wound configuration of the sensor allows the sensor to be arranged inside a container, independent of the presence of a cartridge. Since the cartridge is inserted into the container of the device, within the internal winding of the sensor, at least one physical or chemical parameter of the cartridge and / or its liquid medicament can actually be measured. Since the sensor is integrally assembled inside the housing of the drug delivery device, the cartridge does not require any modification to perform the intended measurement. The sensor described in the present application is configured to operate with conventional cartridges that are typically used to inject medicaments, typically by using a pen-type injection device.

[0071] The arrangement of the sensor inside the drug delivery device is particularly advantageous for reusable drug delivery devices, in which the cartridge is intended to be replaced when empty. In this way, all components of the sensor including the electronic components and at least one measuring electrode can be used multiple times, i.e. multiple times with a series of cartridges. No further modifications to the drug delivery device are required for the measurement. When the sensor is implemented as a passive RFID tag or RFID tag, the measurement can be triggered and the measurement result can be further processed by a single electronic device, such as a smartphone or tablet with RFID or NFC functionality.

[0072] The sensor does not necessarily have to be implemented as a passive RFID or NFC device. Since the sensor as a whole is intended to be permanently arranged inside the housing of the drug delivery device, it is also conceivable to provide the sensor with an additional power supply, so that regular or frequent measurements can be performed according to a predefined measurement schedule, regardless of and independently of the presence of RFID or NFC electronic devices. In particular for electronically implemented drug delivery devices, an active sensor design can be implemented instead of passive NFC or passive RFID power management for the sensor. Then, for the operation of the sensor, the existing power supply of the drug delivery device can be used, without the need for an additional power supply like a separate battery.

[0073] In a further embodiment, the drug delivery device container receiving and accommodating the sensor and the cartridge are located in a cartridge holder of the housing. Here, the proximal portion of the cartridge holder actually accommodates the cartridge. In this embodiment, the cartridge is actually arranged inside the drug delivery device and forms a replaceable component thereof. The cartridge holder is further detachably connected to the distal portion of the body of the housing. Typically, the cartridge holder forms the distal portion of the housing, while the body forms the proximal portion of the housing.

[0074] The body further accommodates a drive mechanism, which typically comprises a piston rod. The drive mechanism and its piston rod are typically configured to apply a distally directed pressure to a piston of the cartridge, which seals the proximal end of the cartridge. The drive mechanism of the drug delivery device is particularly configured to advance in a distal direction so as to apply a pressure to the piston of the cartridge to drive the piston of the cartridge in a distal direction, thereby expelling a predetermined amount, thus a dose, of the medicament from the distal outlet of the cartridge. The distal outlet of the cartridge is typically fluidly connected to a needle assembly, such as a double-pointed injection needle, for depositing the medicament in the biological tissue of the patient.

[0075] In a further embodiment, the drug delivery device, in particular the cartridge holder, comprises a fixing element or a fixing structure to fix the wound sensor in its container. For example, it is conceivable that the proximal end of the cartridge holder comprises a number of locking elements or clip features, by which the position of the wound sensor can be fixed inside the container of the cartridge holder. Furthermore, it is conceivable that the fixing element or the fixing structure of the cartridge holder comprises a removable closure, such as a threaded annular ring or a flange-like element, which has an outer diameter matching the outer diameter of the wound sensor and has an inner diameter large enough to receive the tubular barrel of the cartridge therethrough. In this way, the sensor can be fixed inside the container relative to the longitudinal or axial direction, while the cartridge is removably arranged inside the container.

[0076] In the present application, the distal direction refers to the dispensing end of the drug delivery device. When the drug delivery device is implemented as an injection device, the distal end of the drug delivery device faces the injection site of the patient. The proximal end or proximal direction faces the opposite longitudinal direction of the device. When implemented as an injection device such as a pen injector, the proximal end of the drug delivery device can be operated by the user's hand to configure, set and perform the injection procedure.

[0077] The term "drug" or "pharmaceutical" as used herein refers to a pharmaceutical preparation containing at least one pharmaceutically active compound.

[0078] Wherein in one embodiment, the pharmaceutically active compound has a molecular weight of up to 1500 Da and / or is a peptide, protein, polysaccharide, vaccine, DNA, RNA, enzyme, antibody or fragment thereof, hormone or oligonucleotide, or a mixture of the above pharmaceutically active compounds,

[0079] wherein in a further embodiment, the pharmaceutically active compound is useful for treating and / or preventing diabetes or complications associated with diabetes, such as diabetic retinopathy, thromboembolic diseases such as deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis,

[0080] wherein in a further embodiment, the pharmaceutically active compound comprises at least one peptide for use in the treatment and / or prevention of diabetes or complications associated with diabetes, such as diabetic retinopathy,

[0081] In a further embodiment, the pharmaceutically active compound comprises at least one human insulin or a human insulin analog or derivative, glucagon-like peptide (GLP-1) or an analog or derivative thereof, or exendin-3 or exendin-4 or an analog or derivative of exendin-4.

[0082] Insulin analogs are, for example, Gly(A21), Arg(B31), Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin in which the proline at position B28 is substituted by Asp, Lys, Leu, Val or Ala, wherein at position B29, Lys may be substituted by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0083] Insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin; B29-N-(N-fucocholeyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0084] Exendin-4 refers, for example, to exendin-4 (1-39), a peptide with the following sequence: H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.

[0085] The exendin-4 derivative is, for example, selected from the following compounds:

[0086] H-(Lys)4-des Pro36,des Pro37 exendin-4(1-39)-NH2,

[0087] H-(Lys)5-des Pro36,des Pro37 exendin-4(1-39)-NH2,

[0088] des Pro36 exendin-4 (1-39),

[0089] des Pro36[Asp28] exendin-4(1-39),

[0090] des Pro36[IsoAsp28] exendin-4(1-39),

[0091] des Pro36[Met(O)14,Asp28]exendin-4(1-39),

[0092] des Pro36[Met(O)14,IsoAsp28]exendin-4(1-39),

[0093] des Pro36[Trp(O2)25,Asp28]exendin-4(1-39),

[0094] des Pro36[Trp(O2)25,IsoAsp28]exendin-4(1-39),

[0095] des Pro36[Met(O)14Trp(O2)25,Asp28]exendin-4(1-39),

[0096] des Pro36[Met(O)14Trp(O2)25,IsoAsp28]exendin-4(1-39); or

[0097] des Pro36[Asp28] exendin-4(1-39),

[0098] des Pro36[IsoAsp28] exendin-4(1-39),

[0099] des Pro36[Met(O)14,Asp28]exendin-4(1-39),

[0100] des Pro36[Met(O)14,IsoAsp28]exendin-4(1-39),

[0101] des Pro36[Trp(O2)25,Asp28]exendin-4(1-39),

[0102] des Pro36[Trp(O2)25,IsoAsp28]exendin-4(1-39),

[0103] des Pro36[Met(O)14Trp(O2)25,Asp28]exendin-4(1-39),

[0104] des Pro36[Met(O)14Trp(O2)25,IsoAsp28]exendin-4(1-39),

[0105] Among them, group-Lys6-NH2 can bind to the C-terminus of exendin-4 derivatives;

[0106] Or the following sequence of exendin-4 derivatives

[0107] des Pro36 exendin-4(1-39)-Lys6-NH2(AVE0010),

[0108] H-(Lys)6-des Pro36[Asp28]exendin-4(1-39)-Lys6-NH2,

[0109] des Asp28 Pro36,Pro37,Pro38 Exendin-4(1-39)-NH2,

[0110] H-(Lys)6-des Pro36,Pro38[Asp28]exendin-4(1-39)-NH2,

[0111] H-Asn-(Glu)5des Pro36,Pro37,Pro38[Asp28]exendin-4(1-39)-NH2,

[0112] des Pro36, Pro37, Pro38 [Asp28] exendin-4 (1-39) - (Lys) 6-NH2,

[0113] H-(Lys)6-des Pro36,Pro37,Pro38[Asp28] exendin-4(1-39)-(Lys)6-NH2,

[0114] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Asp28]exendin-4(1-39)-(Lys)6-NH2,

[0115] H-(Lys)6-des Pro36[Trp(O2)25,Asp28]exendin-4(1-39)-Lys6-NH2,

[0116] H-des Asp28 Pro36,Pro37,Pro38[Trp(O2)25]exendin-4(1-39)-NH2,

[0117] H-(Lys)6-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]exendin-4(1-39)-NH2,

[0118] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]exendin-4(1-39)-NH2,

[0119] des Pro36, Pro37, Pro38 [Trp (O2) 25, Asp28] exendin-4 (1-39) - (Lys) 6-NH2,

[0120] H-(Lys)6-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]exendin-4(1-39)-(Lys)6-NH2,

[0121] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]exendin-4(1-39)-(Lys)6-NH2,

[0122] H-(Lys)6-des Pro36[Met(O)14,Asp28]exendin-4(1-39)-Lys6-NH2,

[0123] des Met(O)14Asp28 Pro36,Pro37,Pro38 Exendin-4(1-39)-NH2,

[0124] H-(Lys)6-desPro36,Pro37,Pro38[Met(O)14,Asp28]exendin-4(1-39)-NH2,

[0125] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Asp28]exendin-4(1-39)-NH2,

[0126] des Pro36, Pro37, Pro38 [Met(O)14, Asp28] exendin-4(1-39)-(Lys)6-NH2,

[0127] H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Asp28]exendin-4(1-39)-(Lys)6-NH2,

[0128] H-Asn-(Glu)5des Pro36,Pro37,Pro38[Met(O)14,Asp28]exendin-4(1-39)-(Lys)6-NH2,

[0129] H-Lys6-des Pro36[Met(O)14,Trp(O2)25,Asp28]exendin-4(1-39)-Lys6-NH2,

[0130] H-des Asp28 Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25]exendin-4(1-39)-NH2,

[0131] H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Asp28]exendin-4(1-39)-NH2,

[0132] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]exendin-4(1-39)-NH2,

[0133] des Pro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] exendin-4 (1-39) - (Lys) 6-NH2,

[0134] H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]exendin-4(S1-39)-(Lys)6-NH2,

[0135] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]exendin-4(1-39)-(Lys)6-NH2;

[0136] Or a pharmaceutically acceptable salt or solvate of any of the aforementioned exendin-4 derivatives.

[0137] Hormones are, for example, pituitary hormones or hypothalamic hormones or regulatory activity peptides and antagonists thereof, as listed in the Rote Liste, 2008 edition, Chapter 50, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, chorionic gonadotropin, tocopherol), sematotin (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, goserelin.

[0138] The polysaccharide is, for example, a glycosaminoglycan, hyaluronic acid, heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or sulfated, for example a polysulfated form of the above polysaccharide, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a polysulfated low molecular weight heparin is enoxaparin sodium.

[0139] Antibodies are globular plasma proteins (~150 kDa), also known as immunoglobulins, that share a basic structure. They are glycoproteins because they have sugar chains attached to amino acid residues. The basic functional unit of each antibody is the immunoglobulin (Ig) monomer (containing only one Ig unit); secreted antibodies can also be dimers with two Ig units, as with IgA, tetramers with four Ig units such as teleost IgM, or pentamers with five Ig units, such as mammalian IgM.

[0140] The Ig monomer is a "Y" shaped molecule composed of four polypeptide chains; two identical heavy chains and two identical light chains are connected by disulfide bonds between cysteine ​​residues. Each heavy chain is about 440 amino acids long; each light chain is about 220 amino acids long. The heavy and light chains each contain intrachain disulfide bonds that stabilize their folding. Each chain is composed of domains called Ig domains. These domains contain about 70-110 amino acids and are divided into different categories (such as variable or V, constant or C) according to their size and function. They have a characteristic immunoglobulin fold in which two beta sheets create a "sandwich" shape, held together by interactions between conserved cysteines and other charged amino acids.

[0141] There are five types of mammalian Ig heavy chains, denoted α, δ, ε, γ, and μ. The heavy chain types present define the isotype of an antibody; these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively.

[0142] The different heavy chains differ in size and composition; α and γ contain about 450 amino acids and δ contains about 500 amino acids, while μ and ε contain about 550 amino acids. Each heavy chain has two regions, the constant region (C H ) and variable region (V H ). In a species, the constant region is essentially the same in all antibodies of the same isotype, but different in antibodies of different isotypes. Heavy chains γ, α, and δ have a constant region consisting of three tandem Ig domains and a hinge region for increased flexibility; heavy chains μ and ε have a constant region consisting of four immunoglobulin domains. The variable region of the heavy chain is different in antibodies produced by different B cells, but is the same for all antibodies produced by a single B cell or B cell clone. The variable region of each heavy chain is about 110 amino acids long and consists of a single Ig domain.

[0143] In mammals, there are two types of immunoglobulin light chains, which are represented by λ and κ. The light chain has two consecutive domains: a constant domain (CL) and a variable domain (VL). The approximate length of the light chain is 211 to 217 amino acids. Each antibody contains two always identical light chains; in mammals, only one type of light chain, κ or λ, exists for each antibody.

[0144] Although the general structure of all antibodies is very similar, as mentioned above, the unique properties of a given antibody are determined by the variable (V) regions. More specifically, the variable loops, three each in the light chain (VL) and three in the heavy chain (VH), are responsible for binding to the antigen, i.e., antigen specificity. These loops are called complementary determining regions (CDRs). Because the CDRs from the VH and VL domains contribute to the antigen binding site, it is the combination of the heavy and light chains rather than the heavy or light chains alone that determines the final antigen specificity.

[0145] "Antibody fragments" contain at least one antigen-binding fragment as defined above, and exhibit substantially the same function and specificity as the intact antibody from which the fragment is derived. The Ig prototype is cleaved into three fragments by limited proteolytic digestion with papain. Two identical amino-terminal fragments are antigen-binding fragments (Fab), each containing a complete L chain and about half of the H chain. The third fragment is a crystallizable fragment (Fc), which is similar in size but contains the carboxyl termini of two heavy chains connected by their interchain disulfide bonds. Fc contains carbohydrates, complement binding and FcR binding sites. Limited pepsin digestion produces a single F(ab')2 fragment, which contains a Fab fragment and a hinge region, which includes an HH interchain disulfide bond. F(ab')2 is divalent for antigen binding. The disulfide bonds of F(ab')2 can be broken to obtain Fab'. In addition, the variable regions of the heavy and light chains can be fused together to form a single-chain variable fragment (scFv).

[0146] Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts. Acid addition salts are, for example, HCl or HBr salts. Basic salts are, for example, salts having a cation selected from an alkali metal or alkaline earth metal such as Na + , or K + , or Ca 2+ ; or ammonium ion N + (R1)(R2)(R3)(R4), wherein R1 to R4 independently mean: hydrogen, optionally substituted C1-C6 alkyl, optionally substituted C2-C6 alkenyl, optionally substituted C6-C10 aryl or optionally substituted C6-C10 heteroaryl. Further examples of pharmaceutically acceptable salts are described in: "Remington's Pharmaceutical Sciences", 17th edition, Alfonso R. Gennaro (ed.), Mark Publishing Company, Easton, Pa., USA, 1985, and Encyclopedia of Pharmaceutical Technology.

[0147] Pharmaceutically acceptable solvates are, for example, hydrates.

[0148] It will be further apparent to those skilled in the art that various modifications and variations may be made to the present invention without departing from the spirit and scope of the present invention as defined by the claims. In addition, it should be noted that any reference numerals used in the appended claims should not be interpreted as limiting the scope of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0149] The following describes in detail the embodiments of the display device, the driving mechanism and the drug delivery device in conjunction with the accompanying drawings, wherein:

[0150] Figure 1 showing a top view of the sensor in an initial flat or deployed configuration,

[0151] Figure 2 Show according to Figure 1 On the opposite side of the sensor,

[0152] Figure 3 A perspective view showing the orientation and size of the sensor in relation to a cartridge filled with a liquid substance,

[0153] Figure 4 showing a schematic perspective view of a pen injection device,

[0154] Figure 5 Showing a case where the side wall portion of the housing is cut away Figure 4 equipment,

[0155] Figure 6 Show Figure 5 A magnified view of a portion of

[0156] Figure 7 A cross-sectional view of a wound sensor is shown,

[0157] Figure 8 shows a longitudinal cross-section through the entire drug delivery device in the final assembled configuration,

[0158] Fig. 9 shows the first stage of winding or coiling the sensor,

[0159] Fig.10 shows another stage of winding the sensor,

[0160] Fig.11 Showing the final stage of the winding and tightening process,

[0161] Fig.12 shows an intermediate step of winding a sensor according to another embodiment,

[0162] Fig.13 shows the sensor during welding-based fastening of the fastener and the second part,

[0163] Fig.14a -e shows the assembly sequence of the drug delivery device. DETAILED DESCRIPTION

[0164] Figure 1-3 In FIG. 1 , a sensor 10 is shown in different views. The sensor 10 comprises a planar flexible foil 11. The flexible foil 11 has a generally rectangular shape. The flexible foil 11 comprises four side edges 17, 18, 19, 20. The orientation of the wound sensor 10 is given relative to the orientation of a cartridge 50 containing a liquid substance, typically a medicament 51. Figure 8 The cartridge in the final assembled configuration shown inside the drug delivery device 100 is oriented in the longitudinal direction. The outlet end 54 of the cartridge 50 points in the distal direction 1, while the proximal end 55 is oppositely positioned. Figure 3 and 8 It is evident that the proximal end of the cartridge 50 is sealed by a piston 52 which is movable in a longitudinal direction by means of a plunger or piston rod of a drive mechanism 60 of the drug delivery device 100 .

[0165] like Figure 7 , the sensor 10 is intended to be transformed into a wound configuration W. When in the wound configuration, the tubular wound sensor 10 is intended to be oriented parallel to the cartridge 50 inside the drug delivery device 100. Thus, the oppositely positioned side edges 18, 20, also indicated as lateral side edges, extend in the longitudinal direction (z), while the other two side edges 17, 19 are located near the distal end 54 and the proximal end 55 of the cartridge and extend in the transverse direction (u). Thus, the side edge 17 is the distal side edge of the foil 11, while the oppositely positioned side edge 19 is the proximal side edge of the foil 11.

[0166] like Figure 7 As shown, the foil 11 and the entire sensor 10 are wound into a multiple winding or coiled configuration. In this embodiment, the foil can be wound in an almost three-fold manner. The foil 11 is wound to form a first or inner winding 22 surrounding the first winding 22, a second winding 24, and further to form a third or outer winding 26 that substantially surrounds the second winding. When in the wound configuration W, the inner diameter D of the first winding 22 is equal to or slightly larger than the outer diameter of the tubular cartridge 50. In this way, the cartridge 50 can be positioned and inserted into the first winding 22, and thus located inside the wound or coiled sensor 10.

[0167] The sensor 10, in particular its planar flexible foil 11, is divided into three areas, currently indicated as a sensing area 12, a communication area 14 and a protection area 16. In the transverse direction (u), the sensing area 12 is limited by a rear edge 20 and in the opposite transverse direction by the communication area 14. Further in the transverse direction, the communication area 14 is located adjacent to the protection area 16. A lateral edge 18, located opposite the lateral edge 20, forms the free end of the protection area 16. All areas, thus the sensing area 12, the communication area 14 and the protection area 16, extend over the entire longitudinal extension of the sensor 10. So the sensing area 12, the communication area 14 and the protection area 16 all extend from the distal edge 17 to the proximal edge 19.

[0168] In the present embodiment, the sensing zone 12 is provided with two measuring electrodes 32, 34 extending over almost the entire longitudinal extension (z) of the sensing zone 12. The transverse central areas of the measuring electrodes 32, 34 are usually located at a distance from each other corresponding to half the circumference of the cartridge 50. Thus, the two measuring electrodes 32, 34 are located on diametrically opposite side wall portions of the cartridge 50 when in the final assembled configuration.

[0169] In the present embodiment, the generally rectangular shaped electrodes 32, 34 are configured as capacitance measuring electrodes. Therefore, they are operable to measure the capacitance therebetween. Since the electrical sensitivity or dielectric constant of the piston 52 of the cartridge 50 is significantly different from the electrical sensitivity of the liquid substance 51 located therein, the measurement of the capacitance between the two electrodes 32, 34 directly indicates the axial or longitudinal position of the piston 52 inside the cartridge 50.

[0170] In addition to the basic rectangular structure, the electrodes 32, 34 may also be included in a tapered structure in the axial direction. In addition, the electrodes may be trapezoidal, triangular or may include a combination of rectangles and triangles. In particular, by using electrodes with a geometry that changes continuously in the axial direction, a corresponding linearly varying capacity signal may be obtained, such as the piston 52 of the cartridge 50 undergoing a linear axial displacement during the dispensing process. Therefore, the geometry of the electrodes may improve the accuracy and precision of the capacitance measurement. In addition, it is conceivable that a plurality of measuring electrodes are arranged along the longitudinal extension of the flexible foil 11, wherein the measuring electrode pairs at the same or overlapping longitudinal positions may be connected to a specific processor in pairs. By means of a plurality of first and second measuring electrode pairs, wherein the pairs are arranged at different longitudinal positions along the periphery of the barrel of the cartridge, the spatial resolution of the capacitance measurement and therefore the quite high spatial resolution of the piston position may be measured and determined by the processor connected to each measuring electrode pair.

[0171] When implemented as a temperature measuring electrode, the electrode may include a pair of heaters and thermistors, which are arranged in pairs and alternately in the longitudinal direction along the side wall of the cartridge. Typically, the first measuring electrode may include a plurality of parallel oriented but longitudinally separated heaters, while the second electrode includes a correspondingly arranged thermistor placed longitudinally between the heaters of the first measuring electrode. With the aid of the first electrode, thermal energy can be deposited to the side wall of the cartridge. With the aid of the various thermistors, and therefore with the aid of the second electrode, temperature irregularities caused by the position of the piston in the cartridge can be measured and determined. Typically, each branch of the first and second electrodes forming a heater or thermistor can be individually connected to a processor of the sensor assembly. In this way, thermal excitation and heat transfer across the side wall of the cartridge can be monitored with spatial resolution depending on the distance of adjacent branches of the first and second electrodes.

[0172] When configured and implemented as temperature measuring electrodes, the measuring electrodes act as a thermal sensing array or as a thermal flow sensor.

[0173] The sensor 10 further comprises a processor 40, which is electrically connected to both electrodes 32, 34 via various conductors. The processor 40, which is usually implemented as a microcontroller, is operable to trigger and perform measurements with the aid of the electrodes 32, 34. The processor 40 is further configured to process the measurement signals obtainable from the electrodes 32, 34. In addition, the sensor 10 is further equipped with an antenna 44, which is also electrically connected to the processor 40 via at least one conductor 42. With the aid of the antenna 44, the processor 40 is able to communicate with an external electronic device 200, such as Figure 4 Schematically shown in FIG. Typically, the antenna 44 provides wireless communication between the processor 40 and the external electronic device 200. The antenna 44 can be designed as an RFID antenna or an NFC antenna. The external electronic device 200 is then implemented as a device with RFID or NFC functionality. The external electronic device 200 can be implemented as a smartphone, a smart watch, a tablet or other electronic and data processing device, which can communicate wirelessly with the processor 40 and thus with the sensor 10.

[0174] The antenna 44 can not only provide wireless data transmission between the processor 40 and the external device 200, but also provide power to the processor 40 and the electrodes 32, 34. Therefore, the sensor 10 can be designed as a passive RFID or NFC tag that does not require its own power supply.

[0175] The antenna 44 is typically located on the side 4 of the flexible foil 11 opposite to the side 3 of the foil 11 on which the electrodes 32, 34 are arranged. While the electrodes 32, 34 are located on the inwardly facing portion of the first winding 22, the position of the antenna 44 is laterally offset in the communication zone 14 and is therefore located on the outwardly facing portion of the second winding 24.

[0176] In addition, the sensor 10 comprises an electric shield 48, which is located on the side 3 opposite to the side 4 on which the antenna 44 is located. In this way, the antenna 44 and the electric shield 48 are electrically separated or insulated by the non-conductive flexible foil 11.

[0177] The electric shield 48 is also electrically connected to the processor 40. The signal obtained from the electric shield 48 can thus be processed so as to discard the actual capacitance measurement value, since the capacitance actually measured by means of the electrodes 32, 34 may have been influenced by external objects, such as the fingers of a person in close proximity to the sensor 10 or in mechanical contact with the sensor 10.

[0178] Arranging all the electrical components of the sensor 10 on a single and common foil 11 is particularly advantageous, because the final electrical or mechanical interconnection between the electrodes 32, 34, the processor 40, the antenna 44 or the electric shield 48 becomes superfluous. In addition, it is intended that all the conductive structures of the sensor 10, i.e. the electrodes 32, 34, the conductor 42, the antenna 44 and the electric shield 48, are connected to the flexible foil 11 by printing or coating. The position and relative orientation of these electronic components or conductive structures are therefore fixed. During the assembly of the sensor inside the drug delivery device 100, it remains essentially unaffected. By using printed or coated conductive structures on the flexible foil 11, a large number of substantially identical sensors 10 can be produced at low cost.

[0179] The electrical shield 48 may include at least two electrodes, each electrode having a comb-like or meander-like structure, wherein such structures are intermeshed and electrically separated. Thus, the electrical shield 48 is used to protect the first and second electrodes 32, 34 from EMI emission.

[0180] Usually and from Figure 1 and Figure 2 It is obvious that the electric shield 48 and the antenna 44 are located on opposite sides 3, 4 of the flexible foil 11. In the winding configuration W, the electric shield 48 is located on the part of the second winding 24 facing the inside, while the antenna 44 is located on the opposite part of the second winding 24 facing the outside. In this way, the antenna 44 is located outside the electric shield 48. In practice, the processor 40 and the measuring electrodes 32, 34 are located on the same side 3 of the flexible foil 11. They can also be located on opposite sides of the foil 11. Then, the electrical contact between the processor 40 and the electrodes 32, 34 can extend through the foil 11. The electrical contact between the antenna 44 and the processor 40 extends through the foil 11. It is also conceivable that the structure of the foil 11 is actually staggered with the processor 40, so that the processor 40 extends through the flexible foil 11. In this way and with respect to the winding configuration W, the processor 40 extends radially inwards from the inside 3 of the flexible foil 11, and radially outwards from the outside 4 of the flexible foil 11.

[0181] The flexible foil 11 further comprises at least a first portion 13, 23 and a second portion 15, 25. In the first portion 13, 23, at least one fastener 33, 36 is positioned connectable to the second portion 15, 25 when the flexible foil 11 is in its wound configuration W. Thus, the first and second portions 13, 23, 15, 25 are selected and defined such that they overlap each other or radially when the flexible foil 11 is rolled or wound. The fastener 33, 36 located in the first portion 13, 23 can then be connected to the second portion 15, 25. Typically, the first and second mutually corresponding portions 13, 15 and 23, 25 are located in different but adjacent windings 22, 24, 26 of the winding configuration W of the flexible foil 11.

[0182] By means of at least one fastener 13, 23, at least any two or even all three of the windings 22, 24, 26 can be fixed to each other and connected to each other because the sensor 10 is in a wound configuration W. In this way, automatic unwinding or unfolding of the sensor 10 can be effectively prevented. This is particularly beneficial for the assembly process of the sensor and the drug delivery device, especially when the rolled or wound sensor 10 is inserted into the housing 80 of the drug delivery device 100 by a longitudinal sliding movement.

[0183] In the presently illustrated embodiments, various fastening techniques are shown. Figure 1 The schematically shown first and second parts 13, 15 are separated by a clear transverse distance d, which corresponds to the circumference of the second winding 24. When in the winding configuration, the first and second parts 13, 15 then overlap each other. The fastener 33 is currently provided by a processor 40 protruding from the plane of the foil 11. The second part 15 contains a recess 35, which is currently configured as a depression in the flexible foil 11 or a through opening in the flexible foil 11. The mutual transverse and longitudinal positions of the processor 40 and the recess 35 are selected so that when the flexible foil 11 is in the winding configuration W, the processor 40 substantially overlaps the recess 35. Then, the protruding processor 40 acting as a fastener 33 can be inserted into the recess 33, even through the second part 15 of the flexible foil 11. In this way, a positive interlocking of at least two consecutive windings 22, 24 or 26 of the flexible foil 11 can be obtained, thereby preventing automatic unwinding or unfolding.

[0184] Additionally or alternatively, it is conceivable that the fastener 36 is located at the lateral edge 18 of the protection zone 16. In this embodiment, the fastener 36 extends over the entire longitudinal extension of the flexible foil 11. An adhesive may be provided on the inner side 3 of the flexible foil 11 so that when in a wound configuration, the adhesive located in the first portion 23 can be connected to the second portion 25 located opposite, thus on the outer side 4 of the wound foil 11. Instead of an adhesive provided or applied on the side edge 18, it is also conceivable that at least the side edge 18 itself is bondable or weldable. Thus, the edge may be physically or chemically treated to provide bonding or welding when, for example, exposed to a bonding agent or welding agent or exposed to thermal energy.

[0185] The use of adhesive or bondable structures at the lateral side edges 18 to form the fasteners 36 results in a relatively smooth tubular outer shape of the wound sensor 10. With the fasteners 36 located at the lateral edges 18, the foil 11 can be wound into a wound configuration W without any radially outwardly protruding sections or portions. In this configuration, the wound sensor 10 is particularly suitable for insertion into the container 90 of the housing 80 of the drug delivery device 100.

[0186] Figure 4-6 8 presents an example of a drug delivery device 100. The drug delivery device 100 is configured as an injection device, in particular a pen-type injection device. The drug delivery device 100 comprises a housing 80. The housing 80 comprises a number of housing components, namely a body 82 for accommodating and positioning the drive mechanism 60. The housing 80 further comprises a cartridge holder 84 to receive the cartridge 50 and to receive and accommodate the wound sensor 10. In addition, the housing 80 comprises a protective cap 86 detachably connected to the cartridge holder 84 to protect at least the distal end thereof.

[0187] The drive mechanism 60 located in the body 82 forming the proximal end of the housing 80 comprises at least one piston rod or piston to apply distally directed pressure to the piston 52 of the cartridge 50. In order to set and dispense a dose of the medicament 51, the drive mechanism 60 comprises a dispensing button 62 and a dose dial 64. By means of the dose dial, a dose of variable size can be selected and set by the user. By pressing the dispensing button 62 forming the proximal end face of the housing 80, a pre-set dose of the medicament 51 can be dispensed, usually by injection.

[0188] The cartridge holder 84 includes a tubular container 90 defined by the side walls of the cartridge holder 84. Fig.14aAs is apparent from the figure, the cartridge holder 84 includes at least one window 88 in the side wall, which allows visual inspection of the cartridge 50 located therein. The distal end of the cartridge holder 84 is provided with a threaded socket to removably connect a needle assembly (usually a needle hub) to the cartridge holder. The double-pointed injection needle can then be extended through the distal through hole of the cartridge holder to pierce the pierceable seal at the outlet end 54 of the cartridge 50.

[0189] In accordance with Figure 6 In the enlarged view of FIG. 8 , the wrapped sensor 10 is arranged within the container 90 of the cartridge holder 84 . Figure 6 Detailed description is given in FIG. 8 for the proximal end of the cartridge holder, in particular the proximal interface that connects the cartridge holder 84 to the body 82. The container 90 of the cartridge holder 84 is limited or confined in the proximal direction by means of a removable closure 85. Figure 6 The illustrated closure 85 comprises a stepped threaded portion 91 extending in a distal direction from the annular closure 85. The closure 85 comprises an outer diameter that is substantially the same as the outer diameter of the proximal end 89 of the side wall of the cartridge holder 84.

[0190] The side wall of the cartridge holder 84 at its proximal end 89 includes a threaded portion 92 which communicates with and corresponds to the threaded portion 91 of the closure 85. Thus, by means of the mutually corresponding threaded portions 91, 92, the closure 85 can be detachably connected to the proximal end 89 of the cartridge holder 84. Figure 6 As is apparent from the figure, the threaded portion 91 of the closure 85 comprises a definite radial thickness. In this way, when the closure 85 is fastened to the cartridge holder 84, the distal end of the threaded portion 91 protrudes radially inwardly from the inner surface of the side wall of the cartridge holder 84. In this way, the distal end of the threaded portion 91 forms a proximal stop 93 for the wound sensor 10. Thus, the coil proximal edge 19 of the wound sensor 10 can axially abut the proximal stop 93 provided by the closure 85.

[0191] In the proximal direction, the threaded portion 91 of the closure 85 is delimited or defined by a radially outwardly extending edge 94 having a radial extension substantially corresponding to the thickness of the side wall of the proximal end of the cartridge holder 84. Figure 6In the assembly configuration shown, the edge 94 of the closure 85 abuts axially against the proximal end face 95 of the side wall of the cartridge holder 84. In this way, the helical fastening of the closure 85 to the cartridge holder 84 can be defined, so that the winding sensor 10 located inside the cartridge holder receptacle 90 is prevented from being squeezed in the longitudinal direction. The closure is usually substantially annular in order to allow longitudinal insertion when the cartridge is passed. It is also conceivable that the cartridge 50 is axially fixed inside the cartridge holder 84 by means of the closure. The through hole of the closure can then be small enough to allow the piston rod to pass through.

[0192] The closure member 85 may include a central through hole at its proximal end to receive the fastening structure of the body 82. For example, Fig.14a As shown, the proximal end of the closure 85 may be provided with an internal thread to threadably engage with a correspondingly shaped threaded portion 81 of the body. Instead of a threaded connection of the cartridge holder 84 and the closure 85, other fastening mechanisms are also conceivable, such as a clip-based fastening mechanism of the cartridge holder 84 and the closure 85. In addition, the connection between the body 82 and the cartridge holder 84 or between the body 82 and the closure 85 may also be configured in the form of a threaded connection or a different type of connection, i.e., for example, a positive interlocking type, such as a clip-based interconnection.

[0193] Figure 9-11 In the embodiment, the winding or coiling of the sensor 10 is shown in three consecutive steps. Figure 7 and 11 In the coiled tubular structure shown, the sensor 10 is coiled on a tubular rod 110 of a coil forming tool 112. To this end, the lateral edges 20 of the flexible foil 11 are initially connected to the outer circumference of the tubular rod 110. Thereafter, the sensor 10 is coiled or wrapped around the outer circumference of the rod 110, thereby forming a first wrap 22, a second wrap 24 and a third wrap 26. Finally, when the opposite lateral edge 18 of the flexible foil 11 is subjected to coiling or wrapping, the adhesive located at the lateral edge 18 is used to connect to the second portion 25 located on the outer side 4 of the flexible foil 11. By means of the adhesive in the first portion 23 of the fastener 36, the side edge 18 can be permanently fixed to the outwardly facing side of the second wrap 24. Thereafter, the tubularly coiled or wrapped sensor 10 thus formed can be removed from the tubular rod 110. It can then be inserted into the container 90 from the proximal end 89 of the cartridge holder 84 towards the distal direction 1, as shown by comparing Fig.14a and 14b Obviously.

[0194] In order to facilitate fastening of the lateral edges 20 to the roll-forming rod 110, the lateral edges may be provided with fixing portions 38. The fixing portions 38 located on the inner side 3 of the rollable flexible foil 11 may be provided with an adhesive that is detachable from the rod 110. In this way and by means of the fixing portions 38 at the lateral side edges 20 of the flexible foil 11, the flexible foil 11 may be temporarily and detachably fixed to the roll-forming rod 110, at least for the duration of forming the wound sensor 10.

[0195] After that, from Fig.14b and Fig.14c As is apparent, the closure 85 is connected to the proximal end 89 of the cartridge holder 84, thereby securing and fixing the wound sensor 10 inside the cartridge holder 84. In a further step of assembly, the closure 85 is connected to the proximal end 89 of the cartridge holder 84, thereby securing and fixing the wound sensor 10 inside the cartridge holder 84. Fig.14c and 14d It is obvious that the cartridge 50 is actually inserted in the longitudinal direction through the closure 85 and into the container 90 of the cartridge holder 84. In the final step of assembly, Fig.14d and 14e It is obvious that the proximal end 89 of the cartridge holder 84, and therefore the proximal end of the closure 85, is connected to the distal end of the body 82 of the housing 80 of the drug delivery device 100. Finally, a protective cap 86 is connected to the cartridge holder 84 or the body 82 to close the cartridge holder 84 and protect the cartridge 50 located therein.

[0196] Fig.12 and 13 , different ways of fastening the fastener 36 to the second part 25 are shown. Here, the fastener 36 comprises a bondable or weldable structure. With the aid of a correspondingly shaped welding or bonding tool 114, such as Fig.12 and 13 As shown, the side edge 18 may be permanently connected or welded to the radially lower second portion 25 of the flexible foil 11. It is particularly conceivable that the welding tool 114 is configured to apply heat to the fastener 36 to form a durable and permanent bond of the side edge 18 to the second wrap 24.

[0197] As an alternative or in addition to the positive locking which may be obtained by the handler 40 protruding from the plane of the flexible foil 11 and intersecting or engaging the recess 35 in the flexible foil 11 , a glued or welded connection of the first part 23 to the second part 25 is conceivable.

[0198] Reference numerals list

[0199] 1 Far-end direction

[0200] 2 Proximal direction

[0201] 3 Inside

[0202] 4 Outer side

[0203] 10 Sensors

[0204] 11 Flexible foil

[0205] 12 Sensing area

[0206] 13 Part 1

[0207] 14 communication area

[0208] 15 Part 2

[0209] 16 Protected Areas

[0210] 17 Edge

[0211] 18 Edge

[0212] 19 Edge

[0213] 20 Edge

[0214] 22 First Winding

[0215] 23 Part 1

[0216] 24 Second Entanglement

[0217] 25 Part 2

[0218] 26 The Third Entanglement

[0219] 32 Measuring electrodes

[0220] 34 Measuring electrodes

[0221] 33 Fasteners

[0222] 35 recess

[0223] 36 Fasteners

[0224] 38 Fixed part

[0225] 40 processors

[0226] 42 Conductor

[0227] 44 Antenna

[0228] 48 Electric Shielding

[0229] 50 Cartridges

[0230] 51 Pharmacy

[0231] 52 Piston

[0232] 54 Exit

[0233] 55 Proximal

[0234] 60 Drive mechanism

[0235] 62 Assign Buttons

[0236] 64 Dose Dial

[0237] 80 Shell

[0238] 81 Threaded part

[0239] 82 body

[0240] 84 Cartridge Holder

[0241] 85 Closure

[0242] 86 Cap

[0243] 88 Window

[0244] 89 Proximal

[0245] 90 Containers

[0246] 91 Threaded part

[0247] 92 Threaded part

[0248] 93 Proximal stop

[0249] 94 Edge

[0250] 95 End face

[0251] 100 Drug Delivery Devices

[0252] 110 bars

[0253] 112 Tools

[0254] 114 Welding tools

Claims

1. A sensor for measuring at least one physical or chemical parameter of a cartridge (50) filled with a liquid substance, the sensor comprising: - a planar flexible foil (11) having a sensing area (12) and a communication area (14) arranged adjacently along a transverse direction (u), - the planar flexible foil (11) further comprises a first portion and a second portion separate from the first portion, - at least one measuring electrode (32, 34), said at least one measuring electrode (32, 34) being located in said sensing area (12) on said flexible foil (11), - in, The flexible foil (11) is capable of being wound into a wound configuration (W), in which the sensing area (12) of the foil (11) forms at least a first inner winding, the inner diameter (D) of the at least first inner winding being equal to or greater than the outer diameter of the cartridge (50), wherein when in the wound configuration (W), the first portion and the second portion at least partially overlap, - a processor (40) electrically connected to the at least one measuring electrode (32, 34), and wherein the at least one measuring electrode (32, 34) is located in the sensing area (12) of the flexible foil (11), and - an antenna (44) located in the communication zone (14) of the flexible foil (11) and electrically connected to the processor (40).

2. The sensor according to claim 1, wherein the at least one measuring electrode (32, 34) is connected to the flexible foil (11) in the region of the sensing zone (12), and wherein the antenna (44) is connected to the flexible foil (11) in the region of the communication zone (14), and wherein the communication zone (14) is separated from the sensing zone (12).

3. The sensor according to claim 2, wherein the flexible foil (11) is electrically insulating and wherein the at least one measuring electrode (32, 34) is permanently and fixedly connected to the flexible foil (11).

4. The sensor according to claim 2 or 3, wherein the antenna (44) is permanently and fixedly connected to the flexible foil (11).

5. The sensor according to the preceding claim 1 or 2, further comprising an electrical shield (48) located on the flexible foil (11) and electrically connected to the processor (40).

6. A sensor according to claim 5, wherein the electrical shielding (48) is located in the communication zone (14) of the flexible foil (11) but on the side (3) of the flexible foil (11) opposite to the side (4) of the flexible foil (11) on which the antenna (44) is located.

7. The sensor according to claim 5, wherein the at least one measuring electrode (32, 34) and the electrical shielding (48) are located on the same side of the flexible foil (11).

8. The sensor according to claim 1 or 2, wherein when the flexible foil (11) is in a wound configuration (W), the communication zone (14) forms a second winding surrounding a first inner winding.

9. A sensor according to claim 8, wherein the flexible foil (11) further comprises a protection zone (16), which is located adjacent to the communication zone (14) and is configured to form a third winding surrounding the second winding when the flexible foil (11) is in a wound configuration (W).

10. The sensor according to claim 1 or 2, further comprising at least one fastener located in the first portion and configured to be connected to the second portion for holding the flexible foil (11) in the wound configuration (W).

11. The sensor according to claim 10, wherein the cartridge (50) is insertable into the at least first inner winding along a longitudinal direction, wherein the longitudinal direction coincides with an axial direction of the first inner winding.

12. The sensor according to claim 10, wherein the fastener in the first portion comprises an adhesive and is bonded to the second portion of the flexible foil (11) when the flexible foil (11) is in a wrapped configuration (W).

13. The sensor according to claim 10, wherein the fastener and the second portion are located on opposite sides (3, 4) of the flexible foil (11).

14. A sensor for measuring at least one physical or chemical parameter of a cartridge (50) filled with a liquid substance, the sensor comprising: - a planar flexible foil (11) having a sensing area (12) and a communication area (14) arranged adjacently along a transverse direction (u), - the planar flexible foil (11) further comprises a first portion and a second portion separate from the first portion, - at least one measuring electrode (32, 34) located in the sensing area on the flexible foil (11), - in, The flexible foil (11) is capable of being wound into a wound configuration (W), in which the sensing area (12) of the foil (11) forms at least a first inner winding, the inner diameter (D) of the at least first inner winding being equal to or greater than the outer diameter of the cartridge (50), wherein in the wound configuration (W) the first portion and the second portion at least partially overlap, - at least one fastener located in the first portion and configured to be connected to the second portion for holding the flexible foil (11) in the wound configuration (W).

15. The sensor according to claim 14, wherein a fastener located in the first portion protrudes from the plane of the flexible foil (11), and wherein the second portion comprises a recess (35) which accommodates the fastener when the flexible foil (11) is in a wound configuration (W).

16. The sensor according to claim 14 or 15, further comprising a processor (40), the processor (40) being electrically connected to the at least one measuring electrode (32, 34), wherein the at least one measuring electrode (32, 34) is located in the sensing area (12) of the flexible foil (11).

17. The sensor according to claim 16, wherein the processor (40) protrudes from the plane of the flexible foil (11) and forms the fastener sized to match the recess (35) of the second portion.

18. A drug delivery device for setting and dispensing a certain dose of a liquid medicament, comprising a housing (80), the housing (80) having a tubular container (90) and a sensor according to any one of claims 1 to 17, the tubular container (90) accommodating a cartridge (50) filled with the medicament, the sensor being arranged and fixed inside the container (90) of a winding structure (W) to receive the cartridge (50) inside the first inner winding.

19. A drug delivery device according to claim 18, wherein the container (90) is located inside a cartridge holder (84) of the housing (80), wherein a proximal portion of the cartridge holder (84) accommodating the cartridge (50) is detachably connected to a distal portion of a body (82) of the housing (80), and wherein the body (82) accommodates a drive mechanism (60), the drive mechanism (60) being configured to apply a distally directed pressure to a piston (52) of the cartridge (50).

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